Peste Gabriela, Bibire Nela, Apostu Mihai, Vlase Aurel, Oniscu Corneliu
Center for Drug Evaluation, Antibiotice S.A., Iasi, Romania.
J Biomed Biotechnol. 2009;2009:736327. doi: 10.1155/2009/736327. Epub 2009 Aug 19.
Liquid chromatography (LC) coupled with mass spectrometry (MS) detection is one of the most powerful analytical tools for organic compound analysis. The advantages of using LC/MS methods over HPLC methods include: selectivity, chromatographic integrity, peak assignment, structural information, and rapid method development. In this paper, a new liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the determination of bisoprolol in human plasma samples, using metoprolol as internal standard and liquid-liquid extraction procedure. The assay has proven to be sensitive, specific and reproducible, suitable to determine the bisoprolol concentration, following a single oral administration of a 10 mg bisoprolol tablet in 22 healthy volunteers, in the bioequivalence study of Bisoprolol 10 mg coated tablets, produced by Antibiotice S.A. versus Concor 10 mg, produced by Merck.
液相色谱(LC)与质谱(MS)检测联用是有机化合物分析中最强大的分析工具之一。使用LC/MS方法相对于HPLC方法的优势包括:选择性、色谱完整性、峰归属、结构信息以及快速的方法开发。本文建立并验证了一种新的液相色谱-串联质谱(LC-MS/MS)方法,用于测定人血浆样品中的比索洛尔,以内标美托洛尔和液-液萃取程序进行。在由Antibiotice S.A.生产的比索洛尔10 mg包衣片与由默克公司生产的康可10 mg的生物等效性研究中,该测定方法已被证明灵敏、特异且可重现,适用于在22名健康志愿者单次口服10 mg比索洛尔片后测定比索洛尔浓度。